MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Model Number 71365705

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  Injury  

Event Description

It was reported that, during thr surgery, the anthology inserter poster hard broke inside the patient.All pieces were recovered.The procedure was completed without delay using a smith and nephew back-up device.No other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirms the strike plate on the stem inserter rod assembly broke off the device.The broken piece was returned.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms this case reports the stem inserter broke inside the patient during use.Per complaint details, all pieces were retrieved, and the procedure was completed without delay using a back-up device.No patient injury or other complications were reported.Therefore, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11587194
• MDR Text Key: 242882939
• Report Number: 1020279-2021-02477
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71365705
• Device Catalogue Number: 71365705
• Device Lot Number: 18LM10222
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention